Skin DepressionsPhase 4NCT04390581
A Study to Evaluate the Effect of Juvederm Volift With Lidocaine on Aging Hands in Participants Age 35 and Older
A Phase 4 study testing Juvéderm® VOLIFT with Lidocaine in people with Skin Depressions and Skin Elasticity, run by Allergan at 1 site in France.
Trial summary
This study will evaluate the effect of Juvederm Volift with Lidocaine, an injectable gel implant, to treat aging hands of participants 35 and older. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Skin Depressions, Skin Elasticity, Skin Laxity
- What is being tested?
- Juvéderm® VOLIFT with Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2020to 6 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- Female and male subjects over 35 years of age
- Has a desire for treatment with hyaluronic acid for skin depressions on both hands
- Must qualify to receive Juvéderm® VOLIFT®™ with Lidocaine as described in the current European Union Juvéderm® VOLIFT®™ with Lidocaine Directions For Use (DFU)
- Accepts the obligation not to receive any other hand cosmetic procedures or treatments at any time during the study (hand creams are permitted)
- Agrees not to change their normal hand care regimen throughout the course of the study.
- Women of childbearing potential must have a negative urine pregnancy test result at baseline (Day 1) and practice a reliable method of contraception throughout the study.
Who cannot join
- All contraindications as described in the current European Union Juvéderm® VOLIFT®™ with Lidocaine Directions For Use (DFU), as supplied with the product.
- Receiving or planning to receive anticoagulant therapy during the course of the study, or received anticoagulant within 10 days prior to study treatment and 3 days after.
- Receiving or is planning to receive anti-inflammatory drugs (oral/injectable corticosteroids or NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., Vitamin E, gingko) for 10 days prior to study treatment and 3 days after
- Undergone hand surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures at any time during the study
- Undergone temporary hand dermal filler injections with any substance within 12 months prior to entry in the study
- Noticeable scarring, active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated
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- Subject with a dental infection (e.g. infected tooth or paradonitis) or have received dental cleaning within one month of such infection
- Subject with history of hypertrophic scarring on hands
- Any fibrosis or scarring or deformities on the hands - History of neurological disease that may affect peripheral neurological function
- Subjects with a history of Raynaud´s disease or phenomenon, or history of other disease that may affect peripheral circulation
- Subjects with a history of autoimmune disease or joint disease or connective tissue disease (e.g., rheumatoid arthritis, lupus, scleroderma etc.)
- Woman pregnant, lactating, or planning to become pregnant at any time during the study
- Received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study
- Subject with any skin disease (acute and/or chronic) on the treated zone, likely to interfere with the measured parameters or to put the subject to an undue risk.
- Subject with multiple allergies, anaphylactic shock history, evolutive allergic pathologies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study Evaluating the Effectiveness of Juvederm Volift With Lidocaine for Treatment of the Aging Hands
This study will evaluate the effect of Juvederm Volift with Lidocaine, an injectable gel implant, to treat aging hands of participants 35 and older.
- Conditions
- Skin Depressions, Skin Elasticity, Skin Laxity
- Being tested
- Juvéderm® VOLIFT with Lidocaine
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juvéderm® VOLIFT with LidocaineDevice
Consists of one injection of Juvéderm® VOLIFT with Lidocaine to both hands no more than 6ml for both hands total on Day 1. Optional on Day 30.
| Study group | Role | What they receive |
|---|---|---|
| Juvéderm® VOLIFT with Lidocaine | Experimental | All participants to be injected with Juvéderm® VOLIFT with Lidocaine in both hands no more than 6ml total per both hands. Optional touch-up will be done on Day 30 according to aesthetic results. Receives: Device: Juvéderm® VOLIFT with Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
At least a 1-point improvement in the Allergan Hand Volume Deficit Scale (AHVDS) by hand from baseline before treatment to 3-month visit.
The Evaluating Investigator will grade each hand using the AHVDS 5-point scale where 0= No visible tendons and veins, 1=No protruding tendons, 2=Protruding tendons, 3=Prominent tendons, 4=Tendons very prominent.
Measured: Month 3
Secondary outcomes (12)
Improvement from baseline to each other post-treatment time points in the Allergan Hand Volume Deficit Scale (AHVDS).
The Evaluating Investigator will grade each hand using the AHVDS 5-point scale where 0= No visible tendons and veins, 1=No protruding tendons, 2=Protruding tendons, 3=Prominent tendons, 4=Tendons very prominent.
Measured: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Investigator improvement from baseline to each post-treatment time point using the Global Aesthetic Improvement Scale (GAIS) Investigator
The Evaluating Investigator will assess the aesthetic improvement of the hands using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Measured: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Subject improvement from baseline to each post-treatment time point using the Global Aesthetic Improvement Scale (GAIS) Subject
The Subject will assess the aesthetic improvement of the hands using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Measured: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in HAND-Q Hand Appearance Scale from baseline before treatment to each post-treatment timepoint
The Subjects will answer the HAND-Q Hand Appearance Scale questionnaire before injection (baseline) and at each time points after injection. One questionnaire will be completed globally for both hands, taking into account the worst hand.
Measured: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in skin roughness from baseline before treatment to each post-treatment timepoint using PRIMOS ® 3D Lite for skin roughness measurements
Measurements of skin microrelief will be performed using PRIMOS ® 3D Lite (Phaseshift Rapid In vivo Measurement Of Skin).
Measured: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in skin moisture from baseline before treatment to each post-treatment timepoint using MoistureMeter D®
MoistureMeter D® (Delfin Technologies) allows to measure water content of biological tissues
Measured: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in skin elasticity from baseline before treatment to each post-treatment timepoint using Cutometer®
MPA 580 Cutometer® (Courage \& Khazaka) is an in vivo non-invasive method to evaluate skin rheological properties: measures of biological extensibility and elasticity variations. Cutaneous skin elasticity measurement will be performed with a 6mm probe
Measured: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Injection Site Reactions (ISRs) evaluated by the subject 30 days after each injection using a subject injection site diary.
Measured: Day 30
Number of patients experiencing one or more treatment emergent adverse events (TEAEs)
The number of patients who experienced one more TEAEs
Measured: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in baseline in hand function based on finger goniometer test that will be used to measure any changes in hand function at each post-treatment timepoint.
A finger goniometer measures range-of-motion (ROM) of finger joints (metacarpophalangeal and interphalangeal). To measure finger flexion and extension.
Measured: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in baseline in hand function based on hand dynamometer test that will be used to measure any changes in hand function at each post-treatment timepoint.
A hand dynamometer measures the maximum isometric strength of the hand and forearm muscles. The preferred and non-preferred hand is assessed in an alternating sequence until 3 trials had been completed per hand.
Measured: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in baseline in hand function based on pinch gauge test that will be used to measure any changes in hand function at each post-treatment timepoint.
A pinch gauge is a hand-held medical device that is used for measuring a patient's hand strength. After the first trial score is recorded, the test is repeated with the same instructions for the second and third trials and for the other hand. The scores of three successive trials for each hand tested is averaged.
Measured: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start20 May 2020
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DepressionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390581
- Sponsor's protocol ID
- MED-MA-FAS-0628
- Status last verified
- Dec 2022
- First submitted
- 7 May 2020
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Evaluating the Effectiveness of Juvederm Volift With Lidocaine for Treatment of the Aging Hands
- ClinicalTrials.gov ID
- NCT04390581
- Acronym / sponsor ID
- MED-MA-FAS-0628
- Conditions
- Skin Depressions, Skin Elasticity, Skin Laxity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 20 May 2020 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of Juvederm Volift with Lidocaine, an injectable gel implant, to treat aging hands of participants 35 and older.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Juvéderm® VOLIFT with Lidocaine | Experimental | Device: Juvéderm® VOLIFT with LidocaineAll participants to be injected with Juvéderm® VOLIFT with Lidocaine in both hands no more than 6ml total per both hands. Optional touch-up will be done on Day 30 according to aesthetic results. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to provide informed consent
- Female and male subjects over 35 years of age
- Has a desire for treatment with hyaluronic acid for skin depressions on both hands
- Must qualify to receive Juvéderm® VOLIFT®™ with Lidocaine as described in the current European Union Juvéderm® VOLIFT®™ with Lidocaine Directions For Use (DFU)
- Accepts the obligation not to receive any other hand cosmetic procedures or treatments at any time during the study (hand creams are permitted)
Key exclusion criteria (15 listed)
- All contraindications as described in the current European Union Juvéderm® VOLIFT®™ with Lidocaine Directions For Use (DFU), as supplied with the product.
- Receiving or planning to receive anticoagulant therapy during the course of the study, or received anticoagulant within 10 days prior to study treatment and 3 days after.
- Receiving or is planning to receive anti-inflammatory drugs (oral/injectable corticosteroids or NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., Vitamin E, gingko) for 10 days prior to study treatment and 3 days after
- Undergone hand surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures at any time during the study
- Undergone temporary hand dermal filler injections with any substance within 12 months prior to entry in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Juvéderm® VOLIFT with LidocaineConsists of one injection of Juvéderm® VOLIFT with Lidocaine to both hands no more than 6ml for both hands total on Day 1. Optional on Day 30. | Device | Juvéderm® VOLIFT with Lidocaine |
Primary outcome
At least a 1-point improvement in the Allergan Hand Volume Deficit Scale (AHVDS) by hand from baseline before treatment to 3-month visit.
Time frame: Month 3
The Evaluating Investigator will grade each hand using the AHVDS 5-point scale where 0= No visible tendons and veins, 1=No protruding tendons, 2=Protruding tendons, 3=Prominent tendons, 4=Tendons very prominent.
12 secondary outcomes
Improvement from baseline to each other post-treatment time points in the Allergan Hand Volume Deficit Scale (AHVDS).
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Investigator improvement from baseline to each post-treatment time point using the Global Aesthetic Improvement Scale (GAIS) Investigator
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Subject improvement from baseline to each post-treatment time point using the Global Aesthetic Improvement Scale (GAIS) Subject
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in HAND-Q Hand Appearance Scale from baseline before treatment to each post-treatment timepoint
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in skin roughness from baseline before treatment to each post-treatment timepoint using PRIMOS ® 3D Lite for skin roughness measurements
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in skin moisture from baseline before treatment to each post-treatment timepoint using MoistureMeter D®
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in skin elasticity from baseline before treatment to each post-treatment timepoint using Cutometer®
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Injection Site Reactions (ISRs) evaluated by the subject 30 days after each injection using a subject injection site diary.
Time frame: Day 30
Number of patients experiencing one or more treatment emergent adverse events (TEAEs)
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in baseline in hand function based on finger goniometer test that will be used to measure any changes in hand function at each post-treatment timepoint.
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in baseline in hand function based on hand dynamometer test that will be used to measure any changes in hand function at each post-treatment timepoint.
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Change in baseline in hand function based on pinch gauge test that will be used to measure any changes in hand function at each post-treatment timepoint.
Time frame: Day 30, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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Skin Roughness, Wrinkle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALLERGAN INC. study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Juvéderm® VOLIFT with Lidocaine in people with Skin Depressions and Skin Elasticity, run by Allergan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At least a 1-point improvement in the Allergan Hand Volume Deficit Scale (AHVDS) by hand from baseline before treatment to 3-month visit. (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.